FDA Official: Modernization Plan Coming Soon

A new plan to “modernize” the technology of the U.S. Food and Drug Administration (FDA) for regulatory use will be coming imminently, a federal official said last week.

The coming arrival in the next month or two is a “bit of a teaser,” said Amy Abernethy, M.D., Ph.D., FDA’s principal deputy commissioner and acting chief information officer, in the keynote address to the third annual Interoperability Forum of the Office of the National Coordinator for Health Information Technology.

Although she did not specify what exactly was coming, she said the “modernization” would include the review of medical product applications, among other goals.

“It will include modernization of FDA infrastructure to make sure we can support emerging uses of artificial intelligence, blockchain, and other technologies,” said Abernethy. “We will be ramping up activities that modernize how we use tech to work with the stakeholder community.”

Previous work with real-time oncology review will be foundational in the “ways to advance this interoperability story in service of a learning health system,” she said.

Earlier in the speech to the forum crowd, Abernethy referred to the Real-Time Oncology Review pilot program. That program allows the applicant to send early data, and receive early feedback.

“As we start to clarify the interfaces for the FDA, we anticipate a landscape where the data are submitted via an API, the FDA reviewers can exchange messages with sponsors in real-time, getting quick answers to questions, and elements of the review package and response letters are generated in electronic environments,” she explained.

“This is a story of data interoperability,” she added, “but as you can also see, it is FDA-centric where most of the data are envisioned as coming from traditional clinical trial mechanisms.”

The FDA previously announced in February it would expand its research collaboration with Flatiron Health and the Information Exchange and Data Transformation (INFORMED)— a project involving real-world evidence from EHRs which had been de-identified.

The U.S. Department of Health and Human Services (HHS) released a report last September highlighting how the 29 different agencies within it—including the FDA—where operating in completely different “data silos.” HHS has since undertaken a “Data Initiative” to interconnect those silos, as Mona Siddiqui, M.D., MPH, chief data officer for HHS, recently told Inside Digital Health™.

The FDA “modernization” project will be coming in the near future, according to Abernethy.

“So, stay tuned in the coming months to hear more about his exciting action plan!” she told the crowd, before taking questions.

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